(49 days)
The ddrCruze™ is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. {Not for mammography}
This represents the combination of the two of the predicate devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. (Used UNMODIFIED ). ddRCruze™ features a fully motorized mobile DR system, wireless connectivity, diagnostic image quality, viewing monitor for image review and system setup which can be positioned on any side of the system for added convenience. The system has a front-view camera for safe maneuverability.
Here's an analysis of the acceptance criteria and study information for the ddRCruze™ device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
This 510(k) summary does not delineate specific, quantifiable acceptance criteria in the traditional sense, such as specific sensitivity or specificity targets. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through a comparison of technical characteristics and intended use. The device's performance is reported by stating its characteristics alongside those of the predicate devices.
Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Characteristic | Predicate Device K101517 (Sedecal) | Predicate Device K100400 (CMT Medical) | New Device ddRCruze™ | Implicit Acceptance Criteria (based on substantial equivalence) |
|---|---|---|---|---|
| Intended Use | Diagnostic radiographic exposures for adults/pediatrics (skull, spine, chest, abdomen, extremities), various patient positions. Not for mammography. | General radiographic examinations (skull, chest, shoulders, spine, abdomen, extremities), excluding fluoroscopy, angiography, mammography. | Diagnostic radiographic exposures for adults/pediatrics (skull, spine, chest, abdomen, extremities), various patient positions. Not for mammography. | Must have the SAME intended use as predicates. |
| Digital Receptor Panel | Pixium PORTABLE 3543pR: Csl coupled to TFT matrix, 144 μm pixel, 2372 x 3000 pixels, 16 bit gray scale | Pixium RAD 4600+ and/or Pixium Portable 3543 (WiFi or Cabled): Csl on amorphous silicon, 144 mm (17x14 inch), 3,000 x 2,372 pixels, 16 bit gray scale | Pixium Portable 3543 EZ Technology: Single A-Si TFT + photodiode plate, Csl Scintillator, 43 cm x 43 cm active area, 3.5 lp/mm spatial resolution, 2880 x 2880 pixels, 148 μm pixel size, 16 bit gray scale. (Cleared in K123005) | Must have comparable or improved technical specifications for image capture (e.g., pixel size, resolution, gray scale). |
| Panel Operating Time (battery life) | 2 Hours | Up to 8 hours | Up to 8 hours | Must be comparable or increased compared to predicates. |
| Panel Communication | Tethered Ethernet or WiFi | Tethered Ethernet or WiFi | Tethered Ethernet or WiFi | Must be the same communication methods as predicates. |
| Generator | 20 kW, 32 kW, 40 kW, 50 kW | Not included | 20 kW, 32 kW, 40 kW, 50 kW | Must have equivalent or comparable generator power options to one or more predicates. |
| Safety | UL Listings and IEC Standards IEC 60601-1 and IEC 60601-1-2, US Performance Standards | UL/CSA Listings and IEC Standards IEC 60601-1 and IEC 60601-1-2, US Performance Standards | UL/CSA Listings and IEC Standards IEC 60601-1 and IEC 60601-1-2, US Performance Standards | Must comply with the SAME relevant safety standards as predicates. |
Study Information
Based on the provided 510(k) summary, the following information can be extracted regarding the studies conducted:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The submission explicitly states "Description of clinical tests: Not applicable." This indicates that no new clinical test set with patient data was used to demonstrate the device's performance. The basis for clearance is substantial equivalence to previously cleared devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. As no clinical test set was used, no ground truth needed to be established by experts for this specific device clearance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set was used.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not conducted as this is a traditional X-ray system, not an AI-assisted diagnostic tool. The submission is for a mobile digital X-ray system comprising hardware (mobile unit, digital panel) and software, all of which had prior clearances or are components of previously cleared systems.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is an imaging system, not a standalone AI algorithm. It requires a human operator and interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No new ground truth was established for this device's clearance. The clearance relies on the established safety and effectiveness of its predicate components and the equivalence of its technical characteristics.
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The sample size for the training set:
- Not Applicable. This submission is for a conventional medical imaging device (X-ray system), not an AI algorithm that requires a training set. The "software" mentioned (PrestoDR Portable) was used unmodified and had prior clearance.
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How the ground truth for the training set was established:
- Not Applicable. No training set was used for this device's clearance.
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510(k) Summary
- Submitter: Swissrav Medical AG . Turbistrasse 25 – 27 CH-6280 Hochdorf, Switzerland Phone +41 41 914 12 12 Fax +41 41 914 12 13 Date Prepared: February 6, 2013 Contact: Markus Bütler, Quality Manager
JUN 2 5 2013
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- Identification of the Device: ddRCruze™ (Digital Mobile Diagnostic X-Ray System); Recommended classification regulation: 21 CFR 892.1650, 892. 1720 Device class: 11, Panel: Radiology, Product code: MQB and IZL
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- A description of the device: This represents the combination of the two of the predicate devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. (Used UNMODIFIED ). ddRCruze™ features a fully motorized mobile DR system, wireless connectivity, diagnostic image quality, viewing monitor for image review and system setup which can be positioned on any side of the system for added convenience. The system has a front-view camera for safe maneuverability.
- Intended for use by a qualified/trained doctor or technician on both 5. Intended use of the device: adult and pediatric subjects for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography) (SAME as predicate)
| Characteristic | Predicate DeviceK101517, Sedecal Mobile DigitalDiagnostic X-Ray Systems(various models),. | PrestoDR Portable, K100400,CMT Medical TechnologiesLTD. | New Device ddRCruze™ |
|---|---|---|---|
| Indications | Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying in theprone or supine position. (Notfor mammography) | The PrestoDR Portable, isintended for use in generalradiographic examinations,wherever conventional screen-film systems may be used,excluding fluoroscopy,angiography andmammography. PrestoDR 4143allows imaging of the skull,chest, shoulders, spine,abdomen, and extremities. | Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographic exposuresof the skull, spinal column, chest,abdomen, extremities, and otherbody parts. Applications can beperformed with the patientsitting, standing, or lying in theprone or supine position. (Notfor mammography) (SAME) |
| Characteristic | Predicate DeviceK101517, Sedecal Mobile DigitalDiagnostic X-Ray Systems(various models),. | PrestoDR Portable, K100400,' CMT Medical TechnologiesLTD. | New Device ddRCruze™ |
| Digital ReceptorPanel(s) | Pixium PORTABLE 3543pR:Pixium* Csl coupled to TFT matrixa:Si-technologyPixel size 144 μmMatrix size 2372 x 3000 pixels16 bit gray scale | Pixium RAD 4600+ and/orPixium Portable 3543 (WiFi orCabled) Pixium© Csl onamorphous silicon technology144 mm 17x14 inch (43.2x34.2cm) 3,000 x 2,372 pixels16 bit gray scale | Pixium Portable 3543 EZTechnology Single A-Si TFT +photodiode plate, Csl Scintillator.Active detector area 43 cm x 43cm, Spatial resolution 3.5 lp/mmActive pixel matrix 2880 x 2880pixels, Pixel size 148 μm16 bit gray scale (Cleared in ourown 510(k): K123005, ddRVersaMotion.) |
| Panel OperatingTime (batterylife) | 2 Hours | Up to 8 hours | Up to 8 hours |
| PanelCommunication | Tethered Ethernet or WiFi | Tethered Ethernet or WiFi | Tethered Ethernet or WiFi |
| Generator | 20 kW 32 kW 40 kW 50 kW | Not included | 20 kW 32 kW 40 kW 50 kW |
| Safety | UL Listings and IEC Standards IEC60601-1 and IEC 60601-1-2, USPerformance Standards | UL/CSA Listings and IECStandards IEC 60601-1 and IEC60601-1-2, US PerformanceStandards | UL/CSA Listings and IEC StandardsIEC 60601-1 and IEC 60601-1-2,US Performance Standards |
| Photo | Image: Sedecal Mobile Digital Diagnostic X-Ray Systems | Image: CMT Medical Technologies LTD | Image: New Device ddRCruze |
Comnarison Table
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- ર્દ . Description of non-clinical tests. The unit has undergone electrical safety and electromagnetic compatibility testing, as well as system integration testing. The technical characteristics of the panel have been measured and included in the bench testing information.
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- Description of clinical tests: Not applicable. Both the mobile system and the digital panel, as well as the software has been previously cleared and is provided unmodified.
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- Conclusions drawn: The nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3, above.
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Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center is a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0003
June 25, 2013
Swissray Medical AG % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LL.C. 1394 25th Street NW BUFFALO MN 55313
Rc: K131314
Trade/Device Name: ddrCruzeTM Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB, IZL Dated: June 10, 2013 Received: June 11, 2013
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind vou, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. F.DA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.ida.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131314
Device Name: ddrCruze™
Indications For Use:
The ddrCruze™ is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. {Not for mammography}
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K131314
Page 1 of 1
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.